PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS

K120934 · Cardinal Health, Inc. · KGO · May 23, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K120934
• Device Name: PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS
• Applicant: Cardinal Health, Inc.
• Product Code: KGO · General, Plastic Surgery
• Decision Date: May 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4460
• Device Class: Class 1
• Attributes: 3rd-Party Reviewed

Intended Use

A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

Device Story

Protexis Latex Basic is a disposable, sterile, powder-free surgical glove made of natural rubber latex. Designed for use by operating room personnel to protect surgical wounds from contamination. Features include hand-specific design, independent thumb, and tapered mechanically locking beaded cuffs to prevent roll-down. Device is tan in color and meets ASTM D3577 standards for physical properties and freedom from holes. Protein content is limited to 50µg/dm2 or less. Device is used in clinical surgical settings; provides a physical barrier between the clinician's hands and the surgical site to reduce risk of cross-contamination.

Clinical Evidence

No clinical data. Substantial equivalence is based on non-clinical bench testing, including biocompatibility (ISO 10993-1, 10993-10), physical properties, and protein content testing per ASTM D5712.

Technological Characteristics

Material: Natural rubber latex. Design: Hand-specific, independent thumb, beaded cuff. Standards: ASTM D3577 (physical properties, powder residual), ASTM D5712 (protein content), 21 CFR 800.20 (freedom from holes). Biocompatibility: ISO 10993-1, ISO 10993-10. Sterilization: Sterile. Form factor: Disposable surgical glove.

Indications for Use

Indicated for use by operating room personnel to protect surgical wounds from contamination. No specific patient population or contraindications defined.

Regulatory Classification

Identification

A non-powdered surgeon's glove is a device intended to be worn on the hands of operating room personnel to protect a surgical wound from contamination. A non-powdered surgeon's glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.

Predicate Devices

• Ultrafree Sterile Powder-Free Latex/ Surgical Gloves (K964474)

Submission Summary (Full Text)

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K120934

MAY 2 3 2012

Image /page/0/Picture/2 description: The image shows the logo for Cardinal Health. The logo consists of a stylized graphic above the company name. The graphic appears to be three curved lines converging at a point, possibly representing birds in flight or a similar abstract design.

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#### 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

#### PROTEXISTM LATEX BASIC, STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABEL CLAIM OF 50µg/dm2 OR LESS (TAN) (A summary of safety and effectiveness information in accordance with the requirements of 21 CFR 807.92)

Cardinal Health Applicant: 1430 Waukegan Road McGaw Park, IL 60085 Establishment Registration 1423537 Number: Regulatory Affairs Contact: Tatyana Bogdan, RAC Telephone: [phone] Fax: [e-mail] E-mail:

Summary Prepared: May 9, 2012

Protexis Tid Latex Basic, Sterile Latex Powder-Free Surgical Glove with Trade Name: Protein Content Label Claim of 50ug/dm2 or less (Tan) Surgeon's Gloves Common Name:

Classification Name: Surgeon's Gloves

Classification Panel: General and Plastic Surgery

21 CFR 878.4460 Regulation:

Product Code(s): KGO

Legally marketed device(s)

to which equivalence Ultrafree Sterile Powder-Free Latex/ Surgical Gloves (510(k) K964474, product code KGO)

Reason for 510(k) Submission:

New device

Device Description: The proposed device is a disposable device intended for over the counter use and is provided powder-free and sterile. It is made with natural rubber latex and is tan in color. The glove is manufactured using molds that feature independent thumb and tapered mechanically locking cuffs to help reduce cuff roll down.

This powder-free surgeon's glove is a disposable device made of natural Intended Use: rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

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# K120934

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| Characteristic | New Device | Predicate device | |
|------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------|
| Material<br>Composition | ProtexisTM Latex Basic, Sterile<br>Latex Powder-Free Surgical Gloves<br>with Protein Content Label Claim<br>of 50 $\mu$ g/dm2 or less (Tan) | Ultrafree Sterile Latex Powder-Free<br>Surgical Glove (K964474) | |
| Design | Single Use<br>Sterile<br>Powder-free<br>Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated | Single Use<br>Sterile<br>Powder-free<br>Hand Specific<br>Independent Thumb<br>Beaded Cuff<br>Lubricated | |
| Intended Use/<br>Indications for Use | Powder-Free Surgeon's Glove | Powder-Free Surgeon's Glove | |
| Dimensions &<br>Physical Properties | Meets ASTM D3577 | Meets ASTM D3577 | |
| Freedom from<br>Holes | AQL meets 21CFR 800.20 &<br>ASTM D3577 requirements | AQL meets 21CFR 800.20 & ASTM<br>D3577 requirements | |
| Powder Residual | Meets requirements of $\le$ 2.0<br>mg/glove for Powder-Free<br>designation per ASTM D3577 | Meets requirements of $\le$ 2.0 mg/glove<br>for Powder-Free designation per<br>ASTM D3577 | |
| Protein Contents | Contains less than 50 $\mu$ g/dm2 of<br>total water extractable protein per<br>glove as tested per ASTM D5712 | N/A | |
| Powder Residual | ASTM D3577 tested<br>using ASTM standard<br>D6124 | Gloves meet powder level requirements for<br>“Powder-Free” designation per ASTM<br>D3577. Results generated values < 2mg of<br>residual powder per glove. | |
| Protein Content | ASTM D5712, FDA<br>Medical Glove<br>Guidance Manual | Gloves yielded the results of less than 50<br>$\mu$ g/dm² of total water extractable protein per<br>glove | |
| Comparative Performance Information Summary | | | |
| Characteristic | Requirement | New Device | Predicate Device |
| Biocompatibility: | ISO 10993-1 | Meets requirements | Meets requirements |
| Primary Skin Irritation | ISO 10993-10 | Pass | Pass |
| Guinea Pig<br>Maximization | ISO 10993-10 | Pass | Pass |
| Dimensions | ASTM D3577 | Meets requirements | Meets requirements |
| Physical Properties | ASTM D3577 | Meets requirements | Meets requirements |
| Freedom from Holes | 21CFR800.20,<br>ASTM D3577 | Meets requirements | Meets requirements |
| Powder Residual | ASTM D3577 | Meets requirements | Meets requirements |
| Protein Content | ASTM D5712 | Pass | Pass |
| SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF | | | |
| SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION | | | |
| Clinical data is not required. | | | |
| CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA | | | |
| Non-clinical data demonstrates that ProtexisTM Latex Basic, Sterile Latex Powder-Free Surgical | | | |

Cardinal Health, Inc.
Premarket Notification Submission – Traditional 510(k)

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## 20934

Gloves with Protein Content Label Claim (50 micrograms or less) meet the technological characteristics of ASTM D3577 standard, and are as safe, as effective, and performed as well as the legally marketed devices identified in this summary.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three stylized wing segments.

#### Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002

Cardinal Health, Incorporated C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, Illinois 60062

MAY 2 3 2012

Re: K120934

Trade/Device Name: Protexis™ Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 µg/dm4 or less

(Tan)

Regulation Number: 21 CFR 878.4460 Regulation Name: Surgeon's Glove Regulatory Class: I Product Code: KGO Dated: May 10, 2012 Received: May 11, 2012

Dear Mr. Devine:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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#### Page 2 - Mr. Devine

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Anthemments

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

#### Enclosure

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### Indications for Use

### 510(k) Number (if known): K120934

Device Name:

Protexis TM Latex Basic, Sterile Latex Powder-Free Surgical Gloves with Protein Content Label Claim of 50 ug/dm2 or less (Tan)

Indications for Use:

A powder-free sterile surgeon's glove is a disposable device made of natural rubber intended to be worn by operating room personnel to protect a surgical wound from contamination.

#### Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

#### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth D. Clavin-Willis

(Division Sign-Off) (Division Sign On)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K120934

Cardinal Health, Inc. Oardinal Houkh, Submission -- Traditional 510(k)

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